Kwangdong Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. In cases requiring greater LDL cholesterol reduction, it may be started at 20 mg or 40 mg once daily. Generally, it is administered within the range of 10-80 mg once daily, adjusting dosages based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2-4 weeks after administration to adjust the dose accordingly. The goal of treatment is to reduce LDL cholesterol levels; therefore, monitoring LDL cholesterol levels is recommended during treatment initiation and evaluation. If LDL cholesterol levels cannot be monitored, total cholesterol levels should be used to monitor treatment response. The dosage for homozygous familial hypercholesterolemia patients is 10-80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are not possible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg daily, with a recommended maximum dose of 20 mg daily (no clinical data exist for doses higher than 20 mg in this age group). Dosing should be adjusted appropriately based on the individual treatment goals of each patient. Doses should be adjusted at intervals of 4 weeks or more. Patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effect of atorvastatin, so adjustment of the dose is not necessary. Elderly patients: The efficacy and safety in elderly patients over 70 years of age are similar to those in the general adult population.

Child dose

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum dose of 20 mg once daily. Doses should be adjusted based on treatment goals at intervals of 4 weeks or more.

This medication may cause muscle-related side effects. If muscle pain or weakness worsens or if creatine kinase levels increase significantly, discontinue use immediately and consult a healthcare professional. This medication should not be used in patients with certain liver diseases or severely impaired liver function, in pregnant or potentially pregnant women, in breastfeeding women, in children under 10 years of age, and in patients taking certain other medications. Patients with a history of alcohol abuse or liver disease, impaired kidney function, hypothyroidism, and elderly patients should exercise caution while using this medication, and liver and muscle conditions should be monitored through regular check-ups. Although side effects of this medication are generally mild and transient, various symptoms such as indigestion, headaches, muscle pain, fatigue, and allergic reactions may occur, and persistent unusual symptoms should be reported to a healthcare professional. Particularly, since this medication may affect liver function, if symptoms of hepatitis or jaundice occur, discontinue use immediately and seek medical attention. This medication may interact with other drugs, so patients must inform their healthcare providers of any current medications, especially when taking certain antibiotics, antifungals, some antiviral medications, or grapefruit juice. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should practice appropriate contraception during treatment. The long-term safety and efficacy of this medication in children and adolescents have not been sufficiently studied; thus, caution is advised in patients under 18 years of age. In cases of overdose, there are no specific antidotes, so appropriate treatment should be administered based on symptoms, and liver function and muscle enzyme levels should be monitored regularly. This medication should be stored out of reach of children and in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues with cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, liver abnormalities (jaundice), sudden

Mild side effects

• Weakness
• lethargy
• chest pain
• peripheral edema
• fatigue
• fever
• nasopharyngitis
• hyperglycemia
• hypoglycemia
• weight gain

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is best to keep it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle